The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity

Not Applicable

Interventions: Device: vBloc (Active Device)
Device: Sham (Non-active Device)

Brief Summary: The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity. The Maestro Rechargeable System delivers intermittent, electrical blocking signals to the anterior and posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to reduce sensations of hunger and produce satiety leading to weight loss. After approval from the institutional review board, subjects provided written consent and were randomized in a 2 to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator) or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis. Both groups received similar diet and exercise counseling. Weight, adverse events, clinical laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout the 12 month study duration.

Detailed Description: The Maestro® Rechargeable System is a neuromodulation system.

All subjects will be randomized in a 2:1 allocation to vBloc or Sham.

All subjects will be followed through the 12-month follow-up visit. Subjects in the Sham group who choose to have an active device will undergo a second surgery to receive the active device after study unblinding.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
vBloc (Active Device)	vBloc (Active Device)	The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period
Sham (Non-active Device)	Sham (Non-active Device)	The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).	12 months	To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.
Percentage Responder Rate in the Treatment Arm.	12 months	The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.
Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.	12 months	Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).

Secondary Outcome Measures

Name	Time	Method

Locations (10): Scripps Clinic Nutrition & Metabolic Research Center
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La Jolla, California, United States
Stanford University
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Stanford, California, United States
Mayo Clinic Rochester
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Rochester, Minnesota, United States
Adelaide Bariatric Centre
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Bedford Park, SA, Australia
Institute of Weight Control
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Baulkham Hills, New South Wales, Australia
University of Minnesota
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Minneapolis, Minnesota, United States
Virginia Commonwealth University
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Richmond, Virginia, United States
HonorHealth (formerly Scottsdale Healthcare Bariatric Center)
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Scottsdale, Arizona, United States
Tufts Medical Center
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Boston, Massachusetts, United States
Oregon Health & Science University
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Portland, Oregon, United States